| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TEMOZOLOMIDE | 204159 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2018/07/05 | 2018/07/05 | APOTEX | Discontinued |
| TEMOZOLOMIDE | 204159 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2018/07/05 | 2018/07/05 | APOTEX | Discontinued |
| TEMOZOLOMIDE | 204159 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2018/07/05 | 2018/07/05 | APOTEX | Discontinued |
| TEMOZOLOMIDE | 213328 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2021/11/23 | 2021/11/23 | NIVAGEN PHARMS INC | Discontinued |
| TEMOZOLOMIDE | 213328 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2021/11/23 | 2021/11/23 | NIVAGEN PHARMS INC | Discontinued |
| TEMOZOLOMIDE | 213328 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2021/11/23 | 2021/11/23 | NIVAGEN PHARMS INC | Discontinued |
| TEMOZOLOMIDE | 213328 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2021/11/23 | 2021/11/23 | NIVAGEN PHARMS INC | Discontinued |
| TEMOZOLOMIDE | 213328 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2021/11/23 | 2021/11/23 | NIVAGEN PHARMS INC | Discontinued |
| TEMOZOLOMIDE | 213328 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2021/11/23 | 2021/11/23 | NIVAGEN PHARMS INC | Discontinued |
| TEMOZOLOMIDE | 210030 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2024/08/23 | 2024/08/23 | HETERO LABS LTD V | Prescription |
| TEMOZOLOMIDE | 210030 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2024/08/23 | 2024/08/23 | HETERO LABS LTD V | Prescription |
| TEMOZOLOMIDE | 210030 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2024/08/23 | 2024/08/23 | HETERO LABS LTD V | Prescription |
| TEMOZOLOMIDE | 210030 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2024/08/23 | 2024/08/23 | HETERO LABS LTD V | Prescription |
| TEMOZOLOMIDE | 210030 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2024/08/23 | 2024/08/23 | HETERO LABS LTD V | Prescription |
| TEMOZOLOMIDE | 210030 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2024/08/23 | 2024/08/23 | HETERO LABS LTD V | Prescription |